NCT03339882

Brief Summary

LHRH-a is an important hormone treatment in breast cancer especially in high-risk hormone receptor-positive patients or hormone receptor-negative but needing ovarian function protecting. The climacteric symptoms caused by LHRH-a are often and prominent, which is a common clinical problem.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
85

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2017

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 4, 2017

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

October 15, 2017

Completed
29 days until next milestone

First Posted

Study publicly available on registry

November 13, 2017

Completed
14 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 27, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2018

Completed
Last Updated

July 6, 2018

Status Verified

July 1, 2018

Enrollment Period

11 months

First QC Date

October 15, 2017

Last Update Submit

July 4, 2018

Conditions

Effect of DrugsSafety Issues

Keywords

remifeminpreventive effectLHRH-abreast cancer

Outcome Measures

Primary Outcomes (1)

  • Kupperman Item (KMI)

    Scoring according to Kupperman item scale (Total: 0-48, the score higher the symptoms are severer) which includes of hot flash, sweat, insomnia, anxious, depressed, vertigo, fatigue, arthralgia, headache, palpitate (each item has a weighting coefficient according to four grade scores: no symptom \*0, sometimes \*1, always \*2, influent life \*3).

    3 months after treatment

Secondary Outcomes (1)

  • Disease free survival

    2 years

Study Arms (2)

Remifemin intervention

EXPERIMENTAL

Using Remifemin during LHRH-a treatment in breast cancer

Drug: Remifemin

Control

NO INTERVENTION

No intervention during LHRH-a treatment in breast cancer

Interventions

RemifeminDRUG

Remifemin 0.2g po bid\*12 weeks at the beginning of the LHRH-a treatment

Also known as: cimicifuga racemosa, black cohosh
Remifemin intervention

Eligibility Criteria

Age18 Years - 55 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • provision of informed consent
  • clinical stage I\~IIIC
  • histologically proven invasive breast cancer
  • women defined as premenopausal according to NCCN guideline
  • plan to accept the LHRH-a as endocrine treatment or ovarian function protection

You may not qualify if:

  • clinical evidence of metastatic disease
  • bilateral oophorectomy
  • patients who, for whatever reason (e.g., confusion, infirmity, alcoholism), are unlikely to comply with trial requirements
  • patients who accepted anti-cancer treatment before
  • previous hormonal therapy as adjuvant treatment for non-cancer disease
  • patients unwilling to stop taking any drug known to affect sex hormonal status, or in whom it would be inappropriate to stop previous history of invasive malignancy within the last 5 years, other than squamous or basal cell carcinoma of the skin or carcinoma in situ of the cervix, adequately cone biopsied
  • treatment with a non-approved or experimental drug during 1 month before entry into the study
  • history of bleeding diathesis (i.e., Disseminated intravascular coagulation, clotting factor deficiency), or long term anticoagulant therapy (other than antiplatelet therapy and low dose warfarin)
  • leukopenia and/or thrombocytopenia
  • history of ocular fundus diseases
  • history of thromboembolic diseases
  • history of osteoporotic fractures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310000, China

Location

Related Publications (1)

  • Wang C, Huang Q, Liang CL, Zhang YW, Deng DH, Yu Y, Chen DB, Yang HJ, Yu XF. Effect of cimicifuga racemosa on menopausal syndrome caused by LHRH-a in breast cancer. J Ethnopharmacol. 2019 Jun 28;238:111840. doi: 10.1016/j.jep.2019.111840. Epub 2019 Mar 29.

    PMID: 30935866DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Remifeminblack cohosh root extract

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Xingfei Yu

    Zhejiang Cancer Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 15, 2017

First Posted

November 13, 2017

Study Start

January 4, 2017

Primary Completion

November 27, 2017

Study Completion

January 30, 2018

Last Updated

July 6, 2018

Record last verified: 2018-07

Locations

CN(1)